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OpenTrials
Completed

NCT Number: NCT05312047

Continence After Vaginal Prolapse Surgery

Urinary incontinence after surgical correction of pelvic organ prolapse (POP) could occur. This is a condition that decreases both patients' satisfaction and quality of life. Reports on the prevalence of urinary incontinence after POP surgery are controversial. Concomitant surgery for incontinence could reduce this prevalence, whereas it increases treatment costs and the likelihood of surgical complications. Therefore, it is of paramount importance to know the exact prevalence of urinary incontinence after POP surgery in our population and the potential risk factors associated with this condition.

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Key information

Conditions

Pelvic Organ Prolapse Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Prolapse Signs and Symptoms Urinary Incontinence Urinary Incontinence, Stress Urinary Incontinence, Urge Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year–99 year

Sex eligibility

Female

Study type

Observational

Primary location

Hospital Germans Trias i Pujol, Badalona, Barcelona, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women who will undergo vaginal surgery for pelvic organ prolapse.

Exclusion criteria

  • Inability to give consent to the study.

Treatment and study plan

Pelvic organ prolapse surgery

Procedure

Vaginal surgery of any compartment for pelvic organ prolapse

Primary outcomes

  1. Stress urinary incontinence (SUI).

    Time frame: 1 year after surgery.

    A "Yes" response to any of three questions on the spanish version of the Pelvic Floor Distress Inventory (PFDI) stress incontinence subscale regarding leakage with coughing, sneezing, or laughing; physical exercise; and lifting or bending over (PFDI questions 20, 21 and 22) .

  2. Urgency urinary incontinence (UUI).

    Time frame: 1 year after surgery.

    A "Yes" response to PFDI question 19, "usually experiences urine leakage associated with a feeling of urgency, that is, a strong sensation of needing to go to the bathroom".

Secondary outcomes

  1. Incontinence severity

    Time frame: 1 year after surgery.

    Both SUI and UII severity will be assessed using the spanish versions of the Sandvik's severity index and the International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF).

  2. Patients' satisfaction with the procedure.

    Time frame: 1 year after surgery.

    Assessed with the Patient Impression of Improvement (PGI-I) form.

Sponsors and collaborators

Lead sponsor

Hospital Universitari Vall d'Hebron Research Institute

Other

Collaborators

  • Consorci Sanitari de Terrassa
  • Fundació Hospital de l'Esperit Sant
  • Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
  • Germans Trias i Pujol Hospital
  • Hospital Santa Caterina
  • Hospital Universitari Joan XXIII de Tarragona.
  • Hospital Universitari de Bellvitge
  • Hospital d'Igualada
  • Hospital de Granollers
  • Hospital de Mataró
  • Hospital de Viladecans
  • Hospital del Mar
  • Parc Taulí Hospital Universitari

Registry information

Official study title

Urinary Continence Status After Vaginal Surgery for Prolapse Correction.

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Apr 5, 2022
Registry last updated
Dec 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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